Manufacture of the finished Dosage Form – QbD: New EMA Guideline The European Medicines Agency (EMA) published its new guideline on Manufacture of the finished dosage form on August 14, 2017. The guideline replaces the “Note for Guidance on Manufacture of the Finished Dosage Form” (dated April 1996) and will enter into effect on February 14, 2018. … Read more
Cephalosporins Drugs Cephalosporins are beta-lactam antimicrobials used to manage a wide range of infections from gram-positive and gram-negative bacteria. The five generations of cephalosporins are useful against skin infection, resistant bacteria, meningitis, and other infections. This activity describes the indications, contraindication, and possible adverse effects of cephalosporins and will highlight the mechanism of action, adverse … Read more
SOP for QMS Tools Document Management –Review batch records, stability reports, validation reports, and associated documents required to comply with respective regulatory country GMP. Site Deviations – initiation, investigation, review, closeout, and maintenance for internal and external issues. Change Controls – initiation, review, closeout, and maintenance of all internal and external change controls. CAPA Management – manages … Read more